HEAL Initiative: Non-addictive Analgesic Therapeutics Development [Small Molecules and Biologics] to Treat Pain (UG3/UH3 Clinical Trial Optional)

This contract opportunity from the National Institutes of Health under the Department of Health and Human Services aims to support the development of safe, effective, and non-addictive small molecule and biologic therapeutics for pain treatment. It focuses on accelerating early-stage therapeutic candidates through preclinical optimization to readiness for Phase II clinical trials. Eligible applicants must present a promising lead candidate with strong biological justification and established assays to guide optimization. The funded activities include lead optimization, early development, IND-enabling studies, biomarker development, submission of an Investigational New Drug application, and Phase I clinical testing. The program is structured as a milestone-driven, phased cooperative agreement with active NIH involvement in project planning and monitoring. The solicitation is identified as RFA-NS-27-007, titled HEAL Initiative: Non-addictive Analgesic Therapeutics Development, with clinical trials optional. The solicitation was posted on June 16, 2026, and applicants must respond by February 20, 2029. This federal contract emphasizes collaborative advancement of innovative pain therapeutics while ensuring rigorous oversight from NIH program staff throughout the project lifecycle.